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IWK HEALTH CENTRE TITLE: Procedural Sedation in the Emergency Department NUMBER: 1375 Effective Date: Page: (1 of 13) September, 2013 Applies To: Emergency Department Registered Nurses, Physicians, Consulting Services POLICY Painful procedures are sometimes required in providing care to patients seen in the Emergency Department at the IWK Health Center. Procedural Sedation should be considered for the control of both pain and anxiety. The Emergency Department (ED) health care team will follow this policy and protocol to ensure that procedural sedation for painful procedures is provided in a safe, competent, ethical, and predictable manner. While not an inclusive list some procedures for which sedation may be indicated are as follows: Orthopedic closed reductions/traction Diagnostic imaging Laceration repair Abscess drainage Lumbar puncture Foreign body removal DEFINITIONS Light Sedation: A technique of administering medication to provide anxiolysis to a patient. The patient is able to tolerate the procedure while responding to verbal commands. Ventilatory and cardiovascular functions are unaffected, although cognitive function and coordination may be impaired. (Schneeweiss 2007) Procedural Sedation: A technique of administering sedative or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardio respiratory function. Procedural sedation and analgesia are intended to result in a depressed level of consciousness while allowing the patient to maintain airway control independently and continuously. Specifically, the drugs, doses and techniques used are intended to maintain protective airway reflexes. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 2 of 13 Moderate Sedation/Analgesia: A drug induced depressed level of consciousness in which the patient responds purposefully to verbal commands, either alone or accompanied by tactile light stimulation. No interventions are required to maintain a patent airway and protective reflexes (the ability to handle secretions without aspiration); spontaneous ventilation is adequate. Cardiovascular function is also usually maintained (ASPAN, 2010; Tyler, 2009). Deep Sedation: A medically controlled state of depressed consciousness from which the patient is not easily aroused. It may be accompanied by partial or complete loss of protective reflexes. It may preclude the ability to maintain a patent airway independently. The patient may not respond to physical stimulation or verbal commands (ASPAN, 2012; Tyler, 2009). Patient: For the purpose of this policy the word patient will refer to children and youth undergoing procedural sedation in the Emergency Department. GUIDING PRINCIPLES AND VALUES This policy will provide consistent guidance to healthcare providers in the consistent provision of effective, safe and appropriate sedation, analgesia, anxiolysis, and /or motion control for invasive and non-invasive procedures during an Emergency Department visit. Sedation is a continuum and not easily divided into discrete stages. A patient can progress along the continuum to either a lighter or deeper level of sedation; therefore all levels of sedation require monitoring. The continuum of sedation is not drug specific since patients’ responses to medication can vary considerably. With this in mind, in the emergency department procedures are conducted with the goal of either light/minimal sedation or procedural sedation as defined above. Goals of Procedural Sedation include: 1. 2. 3. 4. 5. Maximize patient safety Minimize pain and discomfort Minimize anxiety and psychological trauma Maximize motion control (immobilization) when required for procedure Maximize the safety of recovery and discharge If a patient arrives in the emergency department directly for a consultant service (i.e. orthopedics, ENT, general surgery, or plastic surgery) and requires procedural sedation, the Pediatric Emergency Medicine (PEM) physician must be informed. Consultant services may provide light sedation without involving the PEM physician. Procedural sedation will be coordinated with the PEM team. The health care team may consider parental or guardian presence for procedural sedation based on procedure and patient assessment. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 3 of 13 PROTOCOL In the interest of family centered care, the goal, where possible, will be to begin the procedural sedation within 1 hour of physician decision to proceed. 1. TIMING Issues in the department, which may impact the timing of a procedural sedation include but are not limited to: o o o o o Overall patient acuity within the department Patient volume within the department Expected arrivals to the ED Nursing, Physician and/or RT available Skills and knowledge of physician and nurse attending the patient The above factors, together with the urgency of the required procedure will be carefully considered by the Charge Nurse, PEM and consulting physician (when involved) when making a decision to proceed with or delay sedation. 2. CANDIDATES Patients are deemed suitable for sedation by the physician if they fulfill the following criteria: o Age greater than 12 months o ASA (American Society of Anesthesiology) Physical Status Classification I or II (See Appendix A). o Procedure is anticipated to take less than 20 minutes o No known allergies to chosen medications o No anticipated airway difficulties Patients with an ASA III should be assessed by the physician on an individual basis, weighing the balance of risks and benefits for each patient. If the pre-sedation assessment of these patients reveals a specific safety concern, consultation with anesthesia may be helpful. Patients who do not fulfill the above criteria should be assessed for sedation on a case-by-case basis to determine if they are suitable for sedation in the emergency department. 3. CONSENT Informed consent for the procedure will be obtained and documented on either the patient’s chart or on the Consent to Treatment and Investigative Procedures Form (Form ID - IWKCOOP) as per health centre policy. The physician attending the sedation procedure will obtain informed consent and assent, where appropriate, by discussing with the patient and family options, risks, and benefits of the sedation. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 4 of 13 The informed consent must be documented by the person obtaining the consent. 4. PRE-SEDATION ASSESSMENT Each patient will receive a focused medical assessment prior to having a procedural sedation. The physician, or delegate, responsible for the procedural sedation will complete the presedation assessment. Ideally, the professional responsible for airway management during the procedure will complete the airway assessment. Information gathered should include but is not limited to: Medical Assessment: o age o weight o vital signs o cardiovascular status including possible coronary disease, hypertension or congestive heart failure o Ensure the patient is euvolemic o respiratory disease including uncontrolled asthma, current upper respiratory tract infection or obstructive sleep apnea o psychiatric disease - specifically psychosis o CNS including increased intracranial pressure or increased intraocular pressure o Other medical issues such as GI reflux, bleeding disorders, obstructive sleep apnea or airway anomalies o home medications/ pre-sedation analgesia o history of previous sedation and relevant reactions o family history of adverse reactions to sedations o pregnancy status o is there an existing IV/CVAD AMPLE Assessment (PALS 2011) Performed in collaboration between the RN and physician A – Allergies M - Medications P – Past medical history L – Last meal (see below **) E – Events leading to need for sedation Airway Assessment The airway assessment should be completed by the person responsible for the airway monitoring. This could be a respiratory therapist, senior resident/fellow as deemed appropriate by the Emergency Physician. o Airway abnormalities such as microagnathia, tonsillar hypertrophy This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 5 of 13 o Dental issues including loose teeth or oral appliances o Physical exam of neck range of motion and jaw opening* o Fasting status** *Although the Mallampati classification is often used, it’s applicability to PSA in children/youth is unknown. **Fasting guidelines: There are no accepted guidelines for the duration of fasting for Emergency Department procedures. Cases need to be assessed on an individual basis. The benefits must outweigh the risks and provide the best care for the child/family. Once identified as a candidate for sedation, the child should be kept NPO. (Roback 2004, Green 2007, Green 2011) The above information will allow the practitioner to assign the appropriate ASA classification to each patient undergoing procedural sedation. See Appendix A. 5. MEDICATION DOSING REFER TO PULSE IWK FORMULARY FOR MEDICATION DOSING AND DRUG INFORMATION Drug Information 6. TEAM ROLES & RESPONSIBILITIES The team involved in procedural sedation will: have knowledge and understanding of the drugs to be administered, their effects and side effects have the knowledge, skill, and clinical judgment to interpret and act upon the monitor parameters have the skills to intervene and manage any potential side effects and complications The following team members are required to perform procedural sedation regardless of the medication used for sedation or whether the procedure is being performed by the ED physician attending or the specialty resident or staff: a. Health care provider responsible for monitoring the airway. Examples include RT, PEM attending, Senior Pediatric or Emergency Medicine resident. An MD and a Respiratory Therapist (RT) are not both required for sedation if there is a second MD with qualified airway skills as backup in the ED and the MD is planning to stay for the duration of the sedation- but both may be present. b. RN responsible for patient monitoring and documentation. If the patient’s condition was to deteriorate or an adverse event develops during a procedural sedation, the RN would call for additional nursing support to assist with interventions as necessary. Consultants would be called on as needed basis depending on the patient’s condition as determined by the physician. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 6 of 13 c. MD responsible for procedure. Examples include consultation service resident or staff, PEM resident or staff. If multiple individuals are required for the procedures, these must be in addition to those identified in (a.) and (b.) above. 7. MONITORING AND DOCUMENTATION Light Sedation Monitoring: A full set of vital signs must be obtained and documented in the patient’s chart, to include RR, HR, BP and oxygen saturation within 4 hours prior to administering medications. MD must be aware of any other pre-procedure medication the patient has received prior to choosing medications for light sedation. Patient will be placed on an oxygen saturation monitor for the duration of the procedure. A responsible person must remain with the child/youth. Advise the caregiver of expected sedative effects. From the time of administration of the medication the patient will be checked every 10 minutes by a Registered Nurse to ensure the patient is not over-sedated. The nurse will check the patient’s level of consciousness, heart rate, respiratory rate and O2 saturation and document the data on the patients chart. Once light sedation has been achieved the RN will notify the ED physician or delegate and the procedure initiated. Equipment set up in room: Oxygen with appropriate sized mask Suction (Yankauer) Procedural Sedation Monitoring by the RN: Patient will be placed on a cardio respiratory monitor prior to the sedation to obtain baseline pre sedation vital signs. These findings will be documented in the patients chart. Patient will remain on a monitor until the sedation is completed and the patient recovers to a Sedation Level 2. (Level 2: Intermittently drowsy, rouses easily to verbal stimuli, obeys commands, opens eyes, slurs speech). See Procedural Sedation Record for sedation levels IWKPASE. Documentation will occur on the procedural sedation record (form IWKPASE) q 5 minutes from the onset of sedation until sedation Level 2 is achieved. If the patient’s condition was to deteriorate or an adverse event develops during a procedural sedation, the RN would call for additional nursing support to assist with interventions as necessary. Consultants would be called on as needed basis depending on the patient’s condition as determined by the physician. Consider checking the patient’s glucose with IV insertion if the patient has been NPO for a prolonged period of time. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 7 of 13 Total dosage of medication will be documented on the medication administration record section of the triage assessment form Emergency Admission/Visit Assessment Form (IWKEMAD). The PEM attending, resident or the RT must remain with the patient until the patient has recovered to Sedation Level 3. (Level 3: frequently drowsy, rouses to verbal and/or non-painful stimuli; requires commands to be repeated). The Pediatric Emergency Medicine will only be able to provide this dedicated care when there is another emergency physician, senior resident or RT available. The Registered Nurse must remain with the patient until the patient has recovered to Sedation Level 2. (Level 2: Intermittently drowsy, rouses easily to verbal stimuli, obeys commands, opens eyes, slurs speech) Monitoring by the RN during the procedure will include: Constant measurement of vital signs using cardio respiratory monitor End tidal CO2 monitoring can be considered Airway patency will be continuously monitored by either the RT or MD Documentation of vitals, including HR, RR, 02, BP and level of sedation will be measured every 5 minutes Behavior of patient (agitation or pain) Equipment set up: Oxygen with appropriate sized mask must functioning and be in the room Suction with Yankauer attached must be functioning and in the room Cardiac monitor Smart Pump Glucometer Airway equipment with appropriately sized facemask with valve and either a Laerdal self-inflating bag or MIE anesthesia bag should be ready in the room. If the bag valve mask is set up it may be attached to the oxygen, but if not used should be returned to its location and not discarded. A complete Crash Cart, stocked with medications and intubation equipment, should be readily available. Drugs: consider having immediately available in room or easily accessible 1. Midazolam to manage recovery agitation and muscular hypertonicity. 2. Succinylcholine or rocuronium to manage laryngospasm in the case that BVM is unsuccessful. The Crash Cart should be easily accessible in case naloxone, flumazenil, dextrose, atropine or other resuscitation drugs are needed. If further doses of antidotes are required the toxin antidote kit should also available in the department. 8. DISCHARGE CRITERIA Patients will be either discharged home with caregivers/or admitted to an inpatient unit following a procedural sedation. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 8 of 13 In all circumstances the patient must meet the following criteria before discharge: o Airway, vital signs, and pulse oximeter readings are stable and back to baseline o Patient can follow age-appropriate commands o Patient is adequately hydrated o Patient is rousable and at baseline level of verbal ability o Patient can sit unaided (if appropriate for age) o Patient should be able to control and maintain their airway independently o Patient is accompanied by a responsible individual Caregivers must be instructed that the child/youth has been given a medication that may cause drowsiness. The medication may also temporarily cause: Clumsiness Poor balance Poor judgment Vomiting o The caregiver must be instructed to watch the child/youth closely for 12 hours. o The Registered Nurse must review written and verbal discharge instructions as per the Discharge Instructions Following Sedation/General Anaesthesia pamphlet (PL0109). o The RN must indicate that the family should call the IWK Emergency Department with further concerns regarding the sedation. REFERENCES American Academy of Pediatrics. 2006. Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures: An Update. Pediatrics. 118(6); 2587-2602. Green, SM. et.al. 2007. Fasting and Emergency Department Procedural Sedation and Analgesia: A Consesus-Based Clinical Practice Advisory. Annals of Emergency Medicine. 49(4): 454-461. Green, SM. et.al. 2009a. Predictors of emesis and recovery agitation with emergency department ketamine sedation: An individual-patient data meta-analysis of 8,282 children. Annals of Emergency Medicine. 54(2); 171-180. Green, SM. et.al. 2009b. Predictors of airway and respiratory adverse events with ketamine sedation in the emergency department: An individual-patient data meta-analysis of 8,282 children. Annals of Emergency Medicine. 54(2): 158-168. Green, SM, et.al. 2011. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 Update. Annals of Emergency Medicine. 57(5): 449-461. IWK Health Centre Formulary of Drugs and Dosing On-line Manual This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 9 of 13 Joseph P Cravero. 2009. Risk and safety of pediatric sedatin/anesthesia for procedures outside the operating room. Current Opinion in Anaesthesiology. 22: 509-513. Orliaguet, GA, et.al. 2012. Case Scenario: Perianesthetic management of laryngospasm in children. Anesthesiology. 116(2): 458-471. Roback, MG. 2004. Preprocedural fasting and adverse events in procedural sedation and analgesia in a pediatric emergency department: Are they related? Annals of Emergency Medicine. 44(5): 454-459. Schneeweiss, S. et.al. 2007. Paediatric Emergency Procedural Sedation Handbook. Division of Paediatric Emergency Medicine The Hospital for Sick Children. Version 1.5. RELATED DOCUMENTS Policies: Administrative Policy # 124 - Consent to Treatment Policy Administrative Policy #324.0A - Beyond Entry Level Competencies (BELCs): Approval of Beyond Entry Level Competencies (BELC) For Nurses at the IWK Health Centre Administrative Policy #324.0B - Beyond Entry Level Competencies (BELCs): Performance of Beyond Entry Level Competencies (BELCs) by Nurses at the IWK Health Centre Forms: Procedural Sedation Record Form ID-IWKPASE Emergency Admission/Visit Assessment Form ID - IWKEMAD Consent to Treatment and Investigative Procedures Form ID - IWKCOOP Brochures: Discharge Instructions Following Sedation/General Anesthesia pamphlet (PL-0109) Appendices: Appendix A: ASA Classification Appendix B: Suggested Management of Potential Complication of Sedation This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 10 of 13 Appendix A: ASA Classification (American Society of Anesthesiology) Physical Status Classification I ll A normally healthy patient A patient with controlled mild systemic disease III A patient with severe systemic disease IV Severe systemic disease that is a constant threat to life V A moribund patient who is not expected to survive without the operation This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 11 of 13 APPENDIX B Suggested Management of Potential Complication of Sedation 1. AIRWAY PROBLEMS A. Hypoventilation: This is reflected as a decreased O2 saturation or an increase in ETCO2. Hypoventilation is the most common airway side effect of sedation. ACTION: Reduce the risk by: o Airway positioning o Oxygen by face mask o Ongoing cardio respiratory monitoring B. Hyper salivation: This is a rare risk with ketamine use. ACTION: o Recovery position if copious secretions and patient still sedated o Oral suctioning if needed (deep suctioning is not usually required and might increase the risk of laryngospasm) o IV Atropine as per Drug Administration Guidelines Pre-treatment with atropine is not recommended (Green 2009b) C. Laryngospasm: The highest risk time for laryngospasm is during initiation and emergence from sedation, when studied in the operating room (Orliaguet 2012). It can be caused by: secretions dripping on vocals cords, sudden rough movement, and aggressive deep suctioning. ACTION: o Airway positioning- chin lift and jaw thrust o Consider placement of an oral airway o O2 by mask at ~10-15L/min o If no air exchange, rapidly assist respirations with oxygenated bag valve mask with positive pressure o Give a paralytic if facemask with valve is unsuccessful – succinylcholine or rocuronium should be in the room during any sedation o Call anesthesia and/or RT (if RT is not already present) o Prepare for intubation D. Chest Wall Rigidity: A complication associated with rapid administration and/or a large dose of fentanyl. ACTION: o Provide positive pressure ventilation with bag-valve mask o Consider administration of naloxone, although rigidity may only be partially relieved. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 12 of 13 o If PPV is unsuccessful administer a paralytic and prepare to intubate. EXCESSIVE SEDATION: Excessive sedation can lead to respiratory arrest. ACTION: o Support airway by positioning, oxygenation and bagging if necessary o RT should be called to assist (if RT is not already present) o Prepare for intubation o Administer antidote to the following drugs, if considered appropriate: Ketamine, and pentobarbital: Provide supportive measures. No antidotes available. Fentanyl: Naloxone as per Drug Administration Guidelines IV/ET. Can be repeated q2-3minutes. Respiratory symptoms may recur once naloxone has worn off. Patient must be closely monitored. Benzodiazepine: Flumazenil as per Drug Administration Guidelines. Wait 1 minute and if no response, give further dose. Individually titrated to the desired response to avoid abrupt awakening. 3. NAUSEA AND VOMITING: More common with use of ketamine and opioids, but may occur in any sedation. ACTION: o Recovery position if patient still sedated o Oral suctioning with a Yankauer o IV or PO ondansetron 3. HYPOTENSION: Hypotension most commonly occurs with use of propofol, opiates, barbituates and benzodiazepines. ACTION: o Provide a rapid fluid bolus o Consider the administration of reversal agents if applicable 5. HYPOGLYCEMIA: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use. Procedural Sedation Page 13 of 13 As some children/youth who undergo procedural sedation have been NPO for prolonged periods of time consider hypoglycemia in patients with persistent decreased level of consciousness. ACTION: o Check glucose o Administer dextrose as needed 6. PERSISTANT AGITATION, HYPERACTIVITY OR HYPERTONICITY: Paradoxical excitation and agitation may be an effect of midazolam or pentobarbital. Agitation or hyperactivity may be seen as emergence reaction to sedation. Ketamine has been shown to occasionally induce myoclonus, twitching and hypertonicity. ACTION: o Provide a quiet, reassuring atmosphere with as little stimulation as possible for agitation or excitation. o Benzodiazepines may be helpful in reducing ketamine agitation, myoclonus or hypertonicity. This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use.